A Quality Calibration Program for
Biotech and Pharmaceutical Companies:
Meeting the FDA requirements
for traceable calibration;
also included...
Paperless Records -
Designing and creating your
own electronic forms.
Course topics include:
Overview of the days agenda
The criticality of calibration
A short history of calibration
Background of FDA
Requirements
21 CFR Part 820.72 (FDA – QSR)
21 CFR Part 820.25 (Training requirements)
21 CFR Parts: 58, 110, 121, 145, 211, and 606
ISO 9000, ISO 13485
A Quality Calibration Program
Calibration procedures – writing them
Formatting
Generic vs. specific types of test instruments
Calibration procedures – using them
Document control
Updating and improving them
Training and availability
Validation vs. qualification
Calibration records
Specific requirements
The required items on a calibration form
Formatting
Filing, electronic and hard copy
How to make corrections to your records
Calibration labels
Calibration intervals
Calibration certificates
Traceability
4:1 – what it is and where it comes from
Uncertainty budgets
The correct way to state NIST traceability
Complying with environmental requirements
Out of tolerance procedures
What should be in place
Examples of forms
Procedures and examples
Solutions for handling missing test equipment
Managing a Quality Calibration Program
Setting up a new metrology department from scratch
Killing three birds with a single pass during your inventory data
collection
Calibration Standards – getting the most bang for your buck
Implementing
a new program
A lab liaison program
Training your customers (internal and external)
Managing a QCP through best practices/lessons learned
Scheduling and inventory control
Calibration management software – they are not all created equal
Continuous process improvements
Short cycling your test instrument’s due dates
Limited calibrations – the pros and cons
PMIs – extending the life of your test equipment
Calibration extension programs – the rare exception to the rule
The SI and the world of measurement
Calibrate Before Use vs. Standardize Before Use programs and labels
Comparing apples/oranges – full scale vs. % of Rdg
Getting the most out of your balances while meeting USP requirements
Accuracy vs. precision
In-house calibration vs. contract and third-party
calibration labs
Quality documents and procedures – when and how to use
administrative procedures
Audit preparation and the paper trail
The responsibilities of a calibration department vs. those of the
customer
Web sites and how they can be a great tool for your quality
calibration program
Ethics
Safety
Resources
Paperless Records using MS Word
(Please bring a laptop w/MS Word 2003)
The difference between a form and a record
Formatting using MS Word
How to use Word and the Form tools
Making templates
Making pre-filled templates
Protecting your forms
Using your forms – cosigning and re-protection
Assist attendees with their individual requirements using MS Word
Hands on practice and
problem solving for those using MS Word for their eRecords
Paperless Records using Adobe Acrobat 8.0 Pro
(Please bring a laptop w/Adobe Acrobat 8.0 Pro installed
if
you want help using it during the workshop)
Modifying your Word form to comply with Adobe Acrobat formatting
Changing your MS Word form into an Adobe Acrobat form
Using the various form tools in Adobe Acrobat
Setting up digital signatures
Lessons learned using Adobe Acrobat
Assist attendees with their individual requirements using Adobe
Acrobat
Hands on practice and problem solving for those using Adobe Acrobat
for their eRecords